The invention relates to a protective case for a blister pack containing medicines.
The invention relates more particularly to a protective case for a blister pack containing medicines intended for clinical trials, of the type comprising a semi-rigid horizontal upper panel comprising blister-shaped cells delimiting housings open at the bottom and which are obturated by covers and each of which contains a medicine able to be expelled by the flat lower face of the blister pack by tearing the cover of the blister.
The case is of the type comprising:                a perforated horizontal bottom upon which the lower face of the blister pack lays; and        a perforated upper panel which covers the upper face of the blister pack;and of the type in which the blister pack is trapped between the bottom and the upper panel each of which comprise holes coinciding with the location of the cells, the case comprising means of fixing the upper panel with respect to the bottom, the bottom and the upper panel of the case being made of rigid plastic.        
A medicine is subjected to clinical tests before being marketed. For example, the effectiveness of the medicine is tested by administering the active constituent to a first group of sick people and by administering a placebo to a second control group of sick-people.
It is known to deliver the medicine sealed in a blister pack in a case in the form of a wallet with which is integrated an information notice relating to the medicine that it contains. The blister pack is trapped in the case, or wallet, in such a way that the medicine is always accompanied by the corresponding notice.
In the context of clinical studies, referred to as double-blind, the cases must be indiscernible from each other whatever their contents may be: placebo or active constituents.
According to a known example, the case consists of a folded sheet of flexible cardboard comprising a central panel flanked by two lateral flaps that can be folded down over the central panel.
The blister pack is trapped between the central panel and a first lateral flap. The central panel and the first flap are each perforated with holes coinciding with the location of the cells. The perforated flap is then folded down and then sealed on the central panel, for example by pasting. The holes in the central panel allow the ejection of the medicine by pressure on the cell and tearing of the cover, the medicine then being retrieved under the lower face of the case.
The second lateral flap forms a protective lid for the cells of the blister pack. The information notice corresponding to the medicines is located on one or both of the faces of the lid.
Such a case in particular makes it possible to use the contents of the blister pack without ever separating the notice. The switching of medicines or a placebo is thus prevented.
Furthermore, any attempt at tampering with the case generally results in visible damage.
However, such a case made of cardboard is flexible and deforms in use. Furthermore, the cardboard is more likely to become deformed if it is exposed to a damp atmosphere.
Furthermore, it can be envisaged that when a case is tampered with, the damage may be camouflaged by pasting the perforated lateral flap back onto the central panel.
Finally, the packaging of the blister pack in such a case necessitates a first operation of positioning of the blister pack in the pre-pasted case and then an operation of pasting the perforated flap onto the central panel, which can take up to 7 seconds.
The document U.S. Pat. No. 3,587,517 describes a case which comprises a rigid bottom upon which a rigid flap is mounted such that it rotates about a lateral hinge. A blister pack of medicine is intended to be inserted flat between the bottom and the flap. The bottom and the flap comprise holes coinciding with the locations of the cells of the blister pack. The case also comprises a rigid lid which is mounted such that it rotates with respect to the bottom between a position folded down over the flap in such a way as to protect the cells from shocks and an open position in which the cells are accessible.
However, this case is not suitable for use in the context of clinical trials. The case is in fact reusable, since the flap comprises reversible means of closure with respect to the bottom. It is therefore possible to substitute the original blister pack with a similar one but containing substances of different nature without the appearance of the case revealing such a substitution. In order for the results of the clinical trials to be reliable, it is therefore essential that the case should be tamper-proof once the blister pack is trapped between the bottom and the flap.